Q. Can you describe the clinical trials?
A. The initial clinical trials involved 17 women ranging in age from 18 to 40. Some were mothers and others had never had children. Five women were dropped from the trail due to noncompliance. The women's initial cup sizes were AA, A, or B. They agreed to use a medically accepted birth control method for the duration of the study and comply with stringent protocol requirements. Volunteers were excluded from the study for the following reasons: positive urine test for pregnancy; breastfeeding; a history of breast surgery or disease; severe breast tenderness and swelling related to menstruation, trauma or pain; presence of a breast mass; severe drooping of the breast; history of chronic dermatitis, and use of hormonal therapy besides birth control pills. The company that developed the Brava will be conducting much larger clinical trials this summer in three major metropolitan areas around the country involving approximately 200 women.